Levsin 0.125mg Oral Tablets
It is used to slow the speed in the stomach and GI (gastrointestinal) tract.It is used to treat diarrhea.It is used to treat GI (gastrointestinal) ulcers.It is used to treat irritable bowel syndrome.It is used to treat muscle spasms of the GI (gastrointestinal) tract, gallbladder system, or urinary system.It is used to treat a runny nose.It is used to treat Parkinson's disease.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antispasmodic, Anticholinergic
Pharmacologic Class
Muscarinic acetylcholine receptor antagonist
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Levsin (hyoscyamine) is a medication used to help relax the muscles in your stomach and intestines. It can reduce cramps, spasms, and pain often associated with conditions like irritable bowel syndrome (IBS) or other digestive problems. It works by blocking certain natural chemicals in your body that cause these muscles to contract.
How to Use This Medicine
Taking Your Medication
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication 30 to 60 minutes before meals. It's also important to note that you should not take antacids at the same time as your medication. If you have any questions about taking antacids with your medication, be sure to ask your doctor.
Storing and Disposing of Your Medication
To keep your medication effective and safe, store it at room temperature in a dry place, away from the bathroom. Keep all medications in a secure location, out of the reach of children and pets. When your medication is no longer needed or has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so. If you're unsure about the best way to dispose of your medication, consult with your pharmacist. You may also want to check if there are any drug take-back programs in your area.
Missing a Dose
If you take your medication on a regular schedule and miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and return to your regular schedule. Do not take two doses at the same time or take extra doses. If you take your medication as needed, be sure not to use it more frequently than directed by your doctor.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication 30 to 60 minutes before meals. It's also important to note that you should not take antacids at the same time as your medication. If you have any questions about taking antacids with your medication, be sure to ask your doctor.
Storing and Disposing of Your Medication
To keep your medication effective and safe, store it at room temperature in a dry place, away from the bathroom. Keep all medications in a secure location, out of the reach of children and pets. When your medication is no longer needed or has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so. If you're unsure about the best way to dispose of your medication, consult with your pharmacist. You may also want to check if there are any drug take-back programs in your area.
Missing a Dose
If you take your medication on a regular schedule and miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and return to your regular schedule. Do not take two doses at the same time or take extra doses. If you take your medication as needed, be sure not to use it more frequently than directed by your doctor.
Lifestyle & Tips
- Take this medication exactly as prescribed by your doctor. Do not take more or less than directed.
- You may take this medication with or without food.
- If you experience dry mouth, try sugar-free candy, gum, or ice chips. Good oral hygiene is important.
- Avoid activities requiring mental alertness, such as driving or operating machinery, until you know how this medication affects you, as it can cause dizziness or drowsiness.
- Avoid overheating during exercise or in hot weather, as this medication can decrease sweating and increase the risk of heatstroke.
- Report any difficulty urinating, blurred vision, or severe constipation to your doctor.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
0.125 mg to 0.25 mg orally every 4 hours as needed
Dose Range:
0.125 - 0.25 mg
Condition-Specific Dosing:
Maximum daily dose:
1.5 mg in 24 hours
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
0.0625 mg to 0.125 mg orally every 4 hours as needed, not to exceed 0.75 mg in 24 hours for children 2-12 years
Adolescent:
0.125 mg to 0.25 mg orally every 4 hours as needed, not to exceed 1.5 mg in 24 hours
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, but use with caution due to potential for increased anticholinergic side effects.
Moderate:
Use with caution; consider lower doses and monitor for anticholinergic effects.
Severe:
Contraindicated in obstructive uropathy; otherwise, use with extreme caution and monitor closely. Significant renal impairment may prolong elimination.
Dialysis:
Not specifically studied; likely not dialyzable due to protein binding and metabolism. Use with extreme caution.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
Use with caution; monitor for increased anticholinergic effects as metabolism may be impaired.
Severe:
Use with caution; monitor for increased anticholinergic effects as metabolism may be significantly impaired.
Pharmacology
Mechanism of Action
Hyoscyamine is a belladonna alkaloid that acts as a non-selective muscarinic acetylcholine receptor antagonist. It competitively inhibits the action of acetylcholine at postganglionic parasympathetic neuroeffector sites, leading to decreased smooth muscle tone and motility in the gastrointestinal tract, urinary tract, and biliary tract. It also reduces glandular secretions (salivary, bronchial, sweat).
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 90%
Tmax:
30-60 minutes (oral tablet)
FoodEffect:
Food may delay absorption but does not significantly affect the extent of absorption.
Distribution:
Vd:
Not precisely quantified, but widely distributed throughout the body.
ProteinBinding:
Approximately 50%
CnssPenetration:
Yes, crosses the blood-brain barrier, leading to CNS effects at higher doses.
Elimination:
HalfLife:
3.5 to 13 hours (variable, average 3.5 hours for immediate release)
Clearance:
Not precisely quantified
ExcretionRoute:
Renal (urine)
Unchanged:
Approximately 13-30% excreted unchanged in urine
Pharmacodynamics
OnsetOfAction:
20-30 minutes (oral tablet)
PeakEffect:
30-60 minutes
DurationOfAction:
4-6 hours (immediate release)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Severe dizziness or fainting
Diarrhea
Confusion
Mood changes
Changes in behavior
Hallucinations (seeing or hearing things that are not there)
Memory problems or loss
Trouble sleeping
Changes in speech
Changes in balance
Changes in eyesight, eye pain, or severe eye irritation
Difficulty urinating
Inability to sweat during physical activity or in warm temperatures
Fever
Flushing
Abnormal or rapid heartbeat
Erectile dysfunction
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Dizziness
Drowsiness
Fatigue
Weakness
Blurred vision
Constipation
Dry mouth
Dry eyes
Headache
Nausea or vomiting
Stomach pain
Changes in taste
Nervousness or excitability
Feeling full or bloated
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Severe dizziness or fainting
Diarrhea
Confusion
Mood changes
Changes in behavior
Hallucinations (seeing or hearing things that are not there)
Memory problems or loss
Trouble sleeping
Changes in speech
Changes in balance
Changes in eyesight, eye pain, or severe eye irritation
Difficulty urinating
Inability to sweat during physical activity or in warm temperatures
Fever
Flushing
Abnormal or rapid heartbeat
Erectile dysfunction
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Dizziness
Drowsiness
Fatigue
Weakness
Blurred vision
Constipation
Dry mouth
Dry eyes
Headache
Nausea or vomiting
Stomach pain
Changes in taste
Nervousness or excitability
Feeling full or bloated
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe or persistent dry mouth
- Blurred vision or eye pain
- Difficulty or inability to urinate
- Severe constipation
- Confusion, agitation, or hallucinations
- Rapid or irregular heartbeat
- Skin rash or hives
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Bowel blockage
+ Bleeding problems
+ Diarrhea
+ Enlarged colon
+ Glaucoma
+ Heart problems
+ Myasthenia gravis
+ Slow-moving gastrointestinal (GI) tract
+ Abnormalities of the esophagus
+ Ulcerative colitis
+ Difficulty urinating
This list is not exhaustive, and it is crucial to discuss all your health problems with your doctor.
Additionally, provide your doctor and pharmacist with a comprehensive list of all the medications you are taking, including:
Prescription medications
Over-the-counter (OTC) medications
Natural products
Vitamins
It is vital to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Bowel blockage
+ Bleeding problems
+ Diarrhea
+ Enlarged colon
+ Glaucoma
+ Heart problems
+ Myasthenia gravis
+ Slow-moving gastrointestinal (GI) tract
+ Abnormalities of the esophagus
+ Ulcerative colitis
+ Difficulty urinating
This list is not exhaustive, and it is crucial to discuss all your health problems with your doctor.
Additionally, provide your doctor and pharmacist with a comprehensive list of all the medications you are taking, including:
Prescription medications
Over-the-counter (OTC) medications
Natural products
Vitamins
It is vital to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Before operating a vehicle or engaging in any activity that requires alertness and clear vision, ensure you understand how this medication affects you.
Consult your doctor before consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may impair your reactions.
Be cautious of heat stroke, particularly in hot weather or during physical activity, as this condition has been reported in individuals taking this drug.
To manage dry mouth, practice good oral hygiene, and consider sucking on hard, sugar-free candy or chewing sugar-free gum. Regular dental check-ups are also recommended.
If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to side effects.
Note that different brands of this medication may be suitable for children of various ages. Therefore, it is crucial to consult with your doctor before administering this drug to a child. Additionally, when using this medication in children, be aware that the risk of certain side effects may be increased.
If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks of this medication with your doctor to ensure the best outcome for you and your baby.
Before operating a vehicle or engaging in any activity that requires alertness and clear vision, ensure you understand how this medication affects you.
Consult your doctor before consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may impair your reactions.
Be cautious of heat stroke, particularly in hot weather or during physical activity, as this condition has been reported in individuals taking this drug.
To manage dry mouth, practice good oral hygiene, and consider sucking on hard, sugar-free candy or chewing sugar-free gum. Regular dental check-ups are also recommended.
If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to side effects.
Note that different brands of this medication may be suitable for children of various ages. Therefore, it is crucial to consult with your doctor before administering this drug to a child. Additionally, when using this medication in children, be aware that the risk of certain side effects may be increased.
If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks of this medication with your doctor to ensure the best outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Severe dry mouth and throat
- Dilated pupils (large pupils)
- Blurred vision
- Flushed, hot, dry skin
- Fever
- Rapid heart rate (tachycardia)
- High blood pressure
- Urinary retention
- Constipation
- Dizziness, drowsiness, confusion
- Agitation, delirium, hallucinations
- Seizures
- Coma
What to Do:
If you suspect an overdose, seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive and may include gastric lavage, activated charcoal, and physostigmine for severe anticholinergic toxicity.
Drug Interactions
Contraindicated Interactions
- Potassium chloride (solid dosage forms) - increased risk of GI lesions due to delayed transit
- Other anticholinergics (e.g., atropine, scopolamine, tricyclic antidepressants, phenothiazines, MAOIs, some antihistamines) - additive anticholinergic effects
Major Interactions
- Opioid analgesics - increased risk of severe constipation and paralytic ileus
- Antacids - may decrease absorption of hyoscyamine (administer hyoscyamine before meals and antacids after meals)
- Digoxin - may increase digoxin levels due to delayed gastric emptying
- Metoclopramide - antagonistic effects on GI motility
- Cholinergic agonists (e.g., bethanechol, pilocarpine) - antagonistic effects
Moderate Interactions
- Antidiarrheals (e.g., kaolin, pectin) - may decrease absorption of hyoscyamine
- Corticosteroids - may increase intraocular pressure
- Nitrates/Nitrites - additive hypotensive effects
- Thiazide diuretics - may enhance hyperthermic effect
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Patient history (glaucoma, prostatic hypertrophy, urinary retention, myasthenia gravis, severe ulcerative colitis, toxic megacolon, obstructive GI disease)
Rationale: To identify contraindications or conditions requiring caution.
Timing: Prior to initiation of therapy
Baseline vital signs (heart rate, blood pressure)
Rationale: To establish baseline and monitor for anticholinergic effects (tachycardia, orthostatic hypotension).
Timing: Prior to initiation of therapy
Routine Monitoring
Symptom relief (e.g., reduction in GI spasms, pain)
Frequency: Ongoing, at each follow-up
Target: Patient-reported improvement
Action Threshold: Lack of efficacy may require dose adjustment or alternative therapy.
Anticholinergic side effects (dry mouth, blurred vision, urinary retention, constipation, tachycardia, CNS effects)
Frequency: Regularly, especially during dose titration and at each follow-up
Target: Minimal to tolerable side effects
Action Threshold: Severe or intolerable side effects may require dose reduction or discontinuation.
Urinary output
Frequency: Periodically, especially in patients at risk for urinary retention (e.g., BPH)
Target: Normal urinary flow
Action Threshold: Decreased output or difficulty voiding requires immediate assessment.
Intraocular pressure (in patients with glaucoma or at risk)
Frequency: Periodically, as clinically indicated
Target: Stable or within therapeutic range
Action Threshold: Significant increase requires ophthalmologic consultation and potential discontinuation.
Symptom Monitoring
- Dry mouth
- Blurred vision
- Difficulty urinating
- Constipation
- Dizziness
- Drowsiness
- Confusion (especially in elderly)
- Palpitations or rapid heart rate
- Headache
- Nausea/vomiting
Special Patient Groups
Pregnancy
Hyoscyamine is Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Trimester-Specific Risks:
First Trimester:
Potential for adverse effects on fetal development, though human data are limited.
Second Trimester:
Risk of anticholinergic effects on the fetus (e.g., tachycardia, decreased fetal movement).
Third Trimester:
Risk of anticholinergic effects on the fetus and neonate (e.g., decreased heart rate variability, urinary retention, paralytic ileus). May inhibit lactation.
Lactation
Hyoscyamine is excreted into breast milk. Use during lactation is generally discouraged due to potential for adverse effects on the infant (e.g., sedation, constipation, dry mouth) and potential to decrease milk production.
Infant Risk:
Moderate risk. Monitor infant for signs of anticholinergic effects (e.g., drowsiness, constipation, dry mouth, urinary retention) and for decreased milk supply in the mother.
Pediatric Use
Use with caution, especially in infants and young children, as they may be more susceptible to the toxic effects of anticholinergic agents. Dosage must be carefully calculated based on age and weight. Contraindicated in children under 2 years for some indications due to lack of established safety and efficacy.
Geriatric Use
Elderly patients are more susceptible to the anticholinergic side effects of hyoscyamine, particularly CNS effects (confusion, memory impairment, delirium), urinary retention, and constipation. Use with caution, starting with lower doses and titrating slowly. Avoid in elderly patients with cognitive impairment or prostatic hypertrophy.
Clinical Information
Clinical Pearls
- Hyoscyamine is often used as an 'as needed' medication for acute GI spasms rather than for continuous prophylaxis.
- Educate patients about common anticholinergic side effects (dry mouth, blurred vision, constipation) and strategies to manage them.
- Warn patients about the risk of heat prostration due to decreased sweating, especially in hot environments or during exercise.
- Carefully assess patients for underlying conditions that are contraindications (e.g., glaucoma, obstructive uropathy, myasthenia gravis).
- Consider the immediate-release formulation for rapid onset of action for acute symptoms, and extended-release for more prolonged control if appropriate.
Alternative Therapies
- Dicyclomine (another anticholinergic antispasmodic)
- Peppermint oil (for IBS symptoms)
- Antidepressants (e.g., TCAs, SSRIs for IBS-related pain)
- Fiber supplements (for constipation-predominant IBS)
- Loperamide (for diarrhea-predominant IBS)
- Rifaximin (for IBS-D)
- Linaclotide, Lubiprostone (for IBS-C)
Cost & Coverage
Average Cost:
Varies widely, typically $20-$100+ per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 or 4 (brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.